North Carolina patient Kathleen Valentini was referred to an orthopedic surgeon after experiencing excruciating pain in her hip that continued to worsen. When an x-ray failed to reveal the cause, the orthopedic surgeon ordered an MRI to determine the source of Valentini’s symptoms.

Valentini’s insurer, however, denied coverage of the MRI, saying that it was medically unnecessary. Group Health Inc (GHI) stated the MRI would only be medically necessary if Valentini failed to improve after 6 weeks of physical therapy, according to federal court documents available on PACER.

The orthopedic surgeon immediately appealed the insurer’s denial. Not only was the MRI necessary, he argued, but Valentini had just completed a full course of physical therapy ― which the insurer had paid for.

Nearly 40 days later, GHI reversed its denial. On March 14, 2019, an MRI revealed sarcoma in Valentini’s right hip. Physicians at Memorial Sloan Kettering in New York gave the Valentinis grim news. Had Valentini come to them a month sooner, oncologists could have proceeded with chemo alone, but physicians would now have to amputate Valentini’s leg, hip, and pelvis.

“It was devastating,” said Steve Cohen, an attorney representing the Valentinis in a lawsuit against the insurer. “Half of her lower body was amputated. This was a healthy, vibrant woman. The doctors did everything right. They recommended the right treatment. They invested the time to get this simple MRI approved. Everybody did the right thing. The insurance company and its utilization review company, we allege, did not.”

A spokesman for EmblemHealth, the parent company for GHI, said the company does not comment on pending litigation. EviCore, the utilization review company, did not respond to messages seeking comment.

Further testing found cancer nodules in Valentini’s right lung. She died 2 years later. The family’s lawsuit contends the insurer’s denial and prolonged prior authorization delayed Valentini’s diagnosis, which resulted in the amputations and led to her dire, long-term prognosis.

The case is one of countless examples of how prior authorizations can interfere with physician treatment and can negatively affect patient care, said Ron Adelman, MD, president for the Connecticut State Medical Society.

Ninety-three percent of physicians report that prior authorizations delay access to necessary care, according to a 2021 survey by the American Medical Association (AMA). Of the physicians surveyed, 82% said that problems related to prior authorization result in patients abandoning treatment, and more than a third of doctors reported that the process had led to a severe adverse event.

The problem is particularly acute for cancer patients, physicians say. Nearly 90% of oncologists called prior authorizations a significant barrier to new medication for patients, and 80% said the process negatively affects patient outcomes, according to a 2022 analysis by Cardinal Health.

Insurance companies and their contracted actors should be held accountable when a delay in a prior authorization negatively affects a patient’s health, Adelman said.

“Prior authorization is destructive to the patient-physician relationship by inserting itself inside the decision-making process, often in ways that are divorced from the realities and necessities of good patient care,” he said. “Ultimately, patients and families suffer when an infection spreads, a cancer grows, and a life, limb, or livelihood is lost due to the prior authorization process.”

America’s Health Insurance Plans (AHIP), a trade association for health insurers, declined to comment on the Valentini case. In general, prior authorizations help deliver the most effective, safest, and most affordable care to patients, said Kristine Grow, AHIP senior vice president for communications.

“[Prior authorization] prevents waste and improves affordability for patients, consumers, and employers,” she said. “Health insurance providers have a comprehensive view of the health care system and each patient’s medical claims history and work to ensure that medications or treatments prescribed by clinicians are safe, effective, and affordable for patients. This results in better outcomes and lower costs for patients. Health insurance providers are implementing innovative solutions to streamline processes, improve the quality of care, reduce costs, and enhance patients’ overall care experience.”

Did Insurer Commit Medical Malpractice?

Valentini, 47, first visited her primary care physician in November 2018 because of pain in her right hip. The physician recommended a conservative course of physical therapy and naproxen.

Valentini followed his instructions and completed the physical therapy, but the pain began radiating down her right leg, and the pain medication did not help, according to court documents. That’s when she visited the orthopedic surgeon who ordered the MRI.

It’s unclear why GHI and eviCore did not recognize that Valentini had already completed physical therapy when they denied the MRI for not completing it, Cohen said. The history was in the medical record, and the orthopedic surgeon conveyed the information himself after the denial.

“The physicians involved were enormously frustrated,” he said. “Despite the doctors pointing out that she had already completed the PT, [the defendants] ignored the evidence and required the doctor to go through the time-consuming appeals process.”

According to attorneys for eviCore, the timing of the coverage determinations was consistent with the utilization review procedures set forth in its policy. After Valentini’s appeal, the original coverage decision was reversed within weeks of the initial request, eviCore attorneys wrote in a court memorandum. They noted that neither the prior authorization nor the appeal were requested on an expedited basis.

Valentini sued the insurer in October 2020, and her estate took over the legal challenge after her death. Among other claims, the family accuses GHI and eviCore of negligence and medical malpractice.

The plaintiffs claim GHI and eviCore owed Valentini “a duty to act reasonably and use due care with respect to her medical care and treatment” and that they breached that duty by overruling the judgment of Valentini’s treating physicians and “wrongfully advising that an MRI was not medically necessary.” They allege Valentini’s injuries resulted from the failure of GHI and their agents to provide good and appropriate medical care.

Attorneys for GHI and eviCore asked a federal court to dismiss the complaint for failure to state a valid claim.

“All of plaintiffs’ tort claims fail for the primary reason that defendants owed no legal duty of care under New York tort law, and the complaint otherwise lacks plausible factual allegations sufficient to support any tort law cause of action,” attorneys wrote in their court memorandum.

In 2021, US District Judge John P. Cronan ruled in favor of GHI and dismissed the complaint. Cronan wrote that the health insurer had no duty of care to Valentini.

“Defendants did not examine Kathleen directly and there are no non-conclusory factual allegations showing they affirmatively provided medical advice,” Cronan wrote in his decision. “Any reliance that Kathleen had on eviCore’s determination was based on her willingness and ability to pay for treatment. This does not give rise to a duty under New York law.”

As for the medical malpractice claim, the judge wrote that the claim fails because Valentini did not have a physician-patient relationship with GHI or eviCore.

The case is not over. Valentini’s family has appealed to the US Appeals Court for the Second Circuit, and they are not alone in their fight. The AMA has filed a brief to the appellate court in support of Valentini, which was joined by the Vermont Medical Society, the Connecticut State Medical Society, and the Medical Society of the State of New York.

“This is an important case because it reveals how there is nothing patient-centric about excessive and unwarranted authorization controls that harm patients when evidence-based care is delayed, denied, and disrupted,” said Jessa Barnard, executive director for the Vermont Medical Society. “We are asking the court to find that eviCore had a duty to Mrs Valentini to help her obtain the medical care she needed, not to obstruct her efforts to secure that care.”

Case Could Have Far-Reaching Effects

The Valentini’s appeal to the Second Circuit centers on whether a health insurer has a duty of care to an insured patient. Attorneys for Valentini argue that well-established New York case law supports a duty of care in this context.

For example, in Kroll v. Landon, the New York Court of Appeals held that Kroll, a drug testing laboratory that had a contract with a county probation office, owed a duty of care to a plaintiff who submitted a sample for testing as a condition of his probation. The duty was present despite the fact that the plaintiff and Kroll had no other relationship or direct contact.

New York courts have also held that a physician employed by an insurance company can be liable for malpractice when they give negligent advice that is relied on by the patient. In Badolato v. Rosenberg,  for instance, the court ruled that “in the context of a physical examination conducted for the purpose of rendering an evaluation for a third party, such as an employer or insurer, an implied physician-patient relationship may arise if the physician either affirmatively treats the examinee or affirmatively advises the examinee as to a course of treatment.”

The Valentini’s medical malpractice claim is based on these standards, according to the family’s appeal.

The AMA and state medical societies are offering an alternative “duty” argument to the Second Circuit. In their brief, the physician associations contend that eviCore’s website indicated the company would act on the patient’s behalf so as to ensure the patient would receive proper medical care.

“Because eviCore held itself out as holding patients’ interests paramount, hoping that it would thereby distinguish itself in the marketplace and generate additional business, it owed Mrs Valentini and other insureds a duty to prioritize their medical needs, not to set up roadblocks by scouring their insurance policies for loopholes under which the insurer could deny benefits,” the associations wrote in their brief. “Its duty included the canonical healthcare obligation: first, do no harm.”

The Second Circuit is expected to hear the case in late fall or early winter 2022.

If the Valentinis are ultimately successful in their suit, the case could have far-reaching implications for health insurers, physicians, and patients.

“A favorable judgment for Mrs Valentini would cause health insurance companies to exercise greater care when they reject or delay payment for medical care through the prior authorization process,” Barnard said.

Insurers would also face more accountability if their prior authorization processes delay diagnoses or impede necessary treatment, adds Cohen. And they would be subject to more legal consequences if preauthorization processes harm patients, he said.

Adelman said a win for the Valentini family would be a victory for all of organized medicine.

“Hopefully, a victory in this case will demonstrate that the consequences of the broken prior authorization process are real, tangible, and, in this case, contributed to the untimely death of the patient,” he said.

Alicia Gallegos is a reporter for Medscape Business of Medicine and is based in the Midwest. She has previously written for the American Medical News, the ACP Internist, and the AAMC Reporter. Contact Alicia at [email protected] or via Twitter at @Legal_med.

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